Clinical Updates — Clinical Updates
Iluvien Receives Marketing Authorization in Belgium for Chronic DME
The Belgian Federal Agency for Medicines and Health Products (FAMHP) has granted marketing authorization to Iluvien (sustained-release fluocinolone acetonide implant; Alimera Sciences, Inc, Atlanta, GA) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The FAMHP approval marks the fourth European approval of Iluvien through the Repeat-Use Procedure and the twelfth approval worldwide. This includes the US Food and Drug Administration’s (FDA) recent approval of Iluvien for the treatment of DME in patients previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).
Iluvien is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom, and the United States, and it is commercially available in the United Kingdom and Germany. It is pending approval in the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, and Poland.
Updated November 12, 2014